PMA P900052S005

Device: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S005
Product code: LNY
Decision date: 1998-10-20
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH(R) II: a smaller (25.4mm. based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.

Current openFDA PMA Record#

Device: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S005
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 1998-10-20
Decision code: APPR
Date received: 1998-04-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH(R) II: a smaller (25.4mm. based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.